1. The Field of the Invention
This invention relates to methods and apparatus used to treat incontinence. More particularly, the present invention is related to methods and apparatus for treating urinary incontinence in females.
2. The Prior Art
Urinary incontinence is a problem which afflicts numerous people in many parts of the world, particularly women and the aged. Urinary incontinence currently plagues 10-35 percent of adults and at least half of the nursing home residents in the United States. More specifically, in the United States, among the population between 15 and 64 years of age, the prevalence of urinary incontinence in men ranges from 1.5 to 5 percent and in women from 10 to 30 percent. For noninstitutionalized persons older than 60 years of age, the prevalence of urinary incontinence ranges from 15 to 35 percent, with women having twice the prevalence of men. Between 25 and 30 percent of those identified as incontinent have frequent incontinence episodes, usually daily or weekly.
Those familiar with the condition will appreciate that urinary incontinence is very prevalent among adult women, mostly in the form of stress incontinence, with many patients benefitting from some kind of treatment. Because of the social stigma of urinary incontinence, many sufferers do not even report the problem to a health care provider. As a result, this medical problem is vastly under diagnosed and under reported.
For individuals which are otherwise capable of caring for themselves, incontinence is particularly embarrassing, causes distress, loss of sleep, and inconvenience for the afflicted individual. Afflicted individuals must also spend money for absorbent pads, diapers, rubber sheeting and for cleaning of soiled clothing.
There are two types of urinary incontinence which are generally recognized: urge incontinence and stress incontinence. The symptom of urge incontinence is the involuntary loss of urine associated with a strong desire to void (urgency). Although urge incontinence can be associated with neurologic disorders, it also occurs in individuals who appear to be neurologically normal.
Stress urinary incontinence is the involuntary loss of urine during coughing, sneezing, laughing, or other physical activities that increase intra-abdominal pressure. The most common cause of stress urinary incontinence in women is urethral hypermobility, or significant displacement of the urethra and bladder neck during exertion when intra-abdominal pressure is raised. Stress urinary incontinence may also be caused by an intrinsic urethral sphincter deficiency, which may be due to congenital sphincter weakness in patients with myelomeningocele, epispadias, or pelvic denervation, or may be acquired after prostatectomy, trauma, radiation therapy, or a sacral cord lesion. In stress urinary incontinence, the urethral sphincter is unable to generate enough resistance to retain urine in the bladder, especially during stress maneuvers. Patients with stress urinary incontinence often leak continuously or with minimal exertion.
When both symptoms are present, the incontinence is called mixed urinary incontinence. Mixed urinary incontinence is common in women, especially older women. Often, however, one symptom (urge or stress) is often more bothersome to the patient than the other. Identifying the most bothersome symptom is important in targeting diagnostic and therapeutic interventions.
Treatments for incontinence include surgery, drug therapy, physical exercises, and electrical stimulation. In the late 1940s, Arnold Kegel described pelvic floor exercises as a treatment option in urinary incontinence. The purpose of the exercises, now often referred to as "Kegal exercises," is to increase the muscle volume and to develop stronger reflex contractions following a quick rise in intra-abdominal pressure. Lack of awareness of these muscles is common in women, and Kegel stressed the importance of learning how to perform the exercises correctly. In controlled studies on the effect of pelvic floor exercises, it has been shown that such exercises resulted in improved urinary continence in women. Jolleys, J. V., "Diagnosis and Management of Female Urinary Incontinence in General Practice" J. R. Coll. Gen. Pract. 1989; 39: 277-9; Lagro-Janssen, T. L. M., Debruyne, F. M., Smits, A. J., Van Weel, C., "Controlled Trial of Pelvic Floor Exercises in the Treatment of Urinary Stress Incontinence in General Practice" Br. J. Gen. Pract. 1991; 41: 445-9. Kegal exercises strengthen the pelvic floor muscles and in many individuals result in improved continence. Importantly, it is preferred that the treatment for incontinence be the least invasive treatment possible and that it be safe, effective, and relatively inexpensive.
To help women gain control over their pelvic floor muscles several devices have been proposed. Kegel developed the perineometer, a pneumatic vaginal rubber tube for recording intravaginal pressure. Kegel, A. H., "Progressive Resistance Exercise in the Functional Restoration of the Perineal Muscles" Am. J. Obstet. Gyncol. 1948; 56: 238-49. It has also been shown that visual feedback of bladder pressure, abdominal pressure, and sphincter activity is more effective than simple verbal performance feedback. Burgio, K. L., "The Role of Biofeedback in Kegel Exercise Training for Stress Urinary Incontinence" Am. J. Obstet. Gynecol. 1986; 154: 58-64. Such devices are too sophisticated, however, for routine use in general practice, and particularly for unsupervised use by a patient.
In an effort to provide a treatment which can be carried out by an unsupervised patient, vaginal cones have been proposed as an aid to pelvic floor muscle training. Typically, one of the cones is inserted and carried in the vagina for 15 minutes twice a day. The vaginal cones provide sensory feedback which makes the pelvic floor contract around the cone and retain it. As the pelvic floor muscles are strengthened, the weight of the cones is gradually increased. It has been shown that vaginal cones have been at least as effective as routine pelvic floor muscle exercises (Kegel exercises) and require less time to teach.
While Kegel exercises and exercises using vaginal cones in many cases provides improved continence for many women, electrical stimulation of the pertinent muscles provides results in many individuals which are as good as, or better than, the other treatments and is still minimally invasive.
The use of transcutaneous electrical stimulation in a body cavity has been available for some time now and is recognized as being safe and effective. Transcutaneous intravaginal electrical stimulation is particularly recognized as being safe and effective for many women suffering from urinary incontinence. Electrical stimulation of the various branches of the pudendal nerve which lead to the muscles of the pelvic floor have been found to cause contraction of these muscles acutely and strengthening of the muscles via stimulation. With adequate electrical stimulation treatment in this manner, the patient may be completely cured of incontinence and may no longer require further assistance or treatment to remain continent.
Transcutaneous electrical stimulation can be used to treat both stress incontinence and urge incontinence. In transcutaneous electrical stimulation, an electrical signal is applied to electrodes inserted into the vagina. The electrical signal is usually in the form of a plurality of pulses. The electrical pulses are transferred by the electrodes to the vaginal wall adjacent to the desired muscles causing contraction of the muscles of the pelvic floor. As a result thereof, the external sphincter of the urethra is constricted, preventing the undesired outward flow of urine. Generally, urge incontinence is treated by short-term maximal stimulation while stress incontinence is usually treated by long-term stimulation of a lower intensity. Eriksen, B. C., Eik-Nes, S., "Long-term Electrostimulation of the Pelvic Floor: Primary Therapy in Female Stress Incontinence?" Urol. Int. 1989; 44: 90-5; Hahn, I., Sommer, S., Fall, M., "A comparative study of pelvic floor training and electrical stimulation for the treatment of genuine female stress urinary incontinence" Neurourol. Urodyn. 1991; 10: 545-54; Eriksen, B. C., "Maximal Electrostimulation of the Pelvic Floor in Female Idiopathic Detrusor Instability and Urge Incontinence" Neurourol. Urodyn. 1989; 8: 219-30.
Significantly, it many be necessary to continue electrostimulation treatments of the pelvic floor muscles for many months to obtain the desired result. Thus, it is very desirable that the patient be able to carry out the electrical stimulation treatment without the immediate supervision of a medical practitioner, preferably in the patient's home. Thus, there is a need to provide a system which allows an individual to treat themselves without the immediate supervision of a health care practitioner.